Brand Names: U.S.

Santyl

Pharmacologic Category

Enzyme, Topical Debridement

Pharmacology

Collagenase is an enzyme derived from the fermentation by Clostridium histolyticum and differs from other proteolytic enzymes in that its enzymatic action has a high specificity for native and denatured collagen in necrotic tissue; collagenase will not attack collagen in healthy tissue or newly formed granulation tissue. Therefore, collagenase is effective for the removal of detritus, formation of granulation tissue, and subsequent epithelization of dermal ulcers and severely burned areas.

Absorption

Topical: Unknown

Use: Labeled Indications

Contraindications

Local or systemic hypersensitivity to collagenase or any component of the formulation.

Dosing: Adult

Dermal ulcers: Topical: Apply once daily (or more frequently if the dressing becomes soiled) until debridement of necrotic tissue is complete and granulation tissue is well established. If infection is present, apply an appropriate topical antibiotic prior to the application of collagenase. If the infection persists despite treatment, discontinue use of collagenase until remission of the infection.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; it is not known if collagenase is absorbed systemically following topical application.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; it is not known if collagenase is absorbed systemically following topical application.

Administration

Prior to application, cleanse the wound of debris and digested material by gently rubbing with a gauze pad saturated with normal saline or another compatible cleansing solution (eg, Dakin’s solution) followed by a normal saline rinse; detergents and antiseptics or soaks containing heavy metal ions (eg, mercury, silver) may decrease the enzymatic activity of collagenase and should be avoided. The enzymatic activity is optimal at a pH range of 6 to 8; precautions should be taken to ensure optimal pH at the application site.

Apply collagenase directly to the wound or to a sterile gauze pad and then apply to the wound and secure. If a thick eschar is present, consider crosshatching with a #10 blade prior to application to allow for more surface contact with necrotic debris; remove as much loosened detritus as can be done readily with forceps and scissors. Application should be carefully confined to the area of the wound; transient erythema may occur in surrounding tissue when application is not confined to the wound.

Storage

Do not store above 25˚C (77˚F).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Frequency not defined.

Local: Application site burning, application site irritation, application site pain

<1% (Limited to important or life-threatening): Hypersensitivity reaction

Warnings/Precautions

Concerns related to adverse effects:

• Local effects: A slight transient erythema has been noted occasionally in the surrounding tissue, particularly when application was not confined to the wound.

Monitoring Parameters

Signs and symptoms of systemic bacterial infection

Pregnancy Considerations

It is not known if collagenase is absorbed systemically following topical application.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.